Approval · Notice of Compliance 25265 · 2021
REPLAGAL: Notice of Compliance 25265
Issued February 19, 2021
A Notice of Compliance is Health Canada’s approval of a drug submission: a new drug, a new use or form, or a change to an approved one. The product itself is in the Drug Product Database, with its current status.
- Notice number
- 25265
- Date
- February 19, 2021
- Company
- Takeda Canada IncorporatedToronto, Ontario, Canada
- Product type
- Biologic
- Submission
- New Drug Submission (NDS)
- Submission class
- Labelling Only
- Reason
- Transfer of drug identification number. labelling updates
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| REPLAGAL | 02249057 | Marketed |
Medicinal ingredients
- AGALSIDASE ALFA 1 MG per ML